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Vaporized Nicotine and Autonomic Control

NCT ID: NCT04613609

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-07-01

Brief Summary

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E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).

Detailed Description

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Conditions

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Electronic Cigarette Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Repeated Measures
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants were not informed if they were to receive nicotine or placebo

Study Groups

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Placebo

E-cigarette containing no nicotine.

Group Type PLACEBO_COMPARATOR

Electronic Cigarette without nicotine

Intervention Type DEVICE

Non-smokers used an electronic cigarette without nicotine

Nicotine

E-cigarette containing nicotine

Group Type ACTIVE_COMPARATOR

Electronic Cigarette containing nicotine

Intervention Type DEVICE

Non-smokers used an electronic cigarette containing nicotine

Interventions

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Electronic Cigarette containing nicotine

Non-smokers used an electronic cigarette containing nicotine

Intervention Type DEVICE

Electronic Cigarette without nicotine

Non-smokers used an electronic cigarette without nicotine

Intervention Type DEVICE

Other Intervention Names

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JUUL (brand name) Smok (brand name)

Eligibility Criteria

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Exclusion Criteria

* Individuals with a history of hyperthyroidism
* Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant
* Individuals currently taking prescription drugs.
* Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.)
* Individuals with hypertension (systolic \>130 and/or diastolic \> 80).
* Individuals with a history of tobacco or vaporized nicotine use.
* Individuals who have been diagnosed with diabetes
* Individuals who are under the age of 18 or over the age of 40
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan Technological University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Michigan Technological University

Houghton, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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M1747

Identifier Type: -

Identifier Source: org_study_id